The purpose of this informational bulletin is to permit Class A licensees to (a) centrally store medications, (b) delegate insulin administration, and (c) receive electronically submitted prescriber orders for clients in Housing with Services settings without having to get a separate Assisted Living Home Care (ALHC) provider license. These provisions are effective August 2, 1999 and are consistent with the scope of ALHC provider licensure. These service options are available only to clients of Class A providers in registered Housing with Service settings. Moreover, Class A licensees must establish a written system to identify which clients are receiving centrally stored medications or insulin administered by unlicensed personnel as delegated by a registered nurse.

Please Note: IT IS NOT necessary to submit any waiver/variance requests to the Department to perform these services if the guidelines set forth in this informational bulletin are followed.

All waivers issued to Class A providers, prior to this bulletin, regarding medication storage and insulin administration, are NULL and VOID

II. CENTRAL STORAGE OF MEDICATION
Variance to MN Rule 4668.0003 Subp. 11

By variance to Mn Rule 4668.0003, Subp. 11, the term "home care service" is expanded to include central storage of medications for clients in Housing with Services Establishments consistent with the requirements of MN Rules 4668.0855, Subp. 9 and 4668.0865. To be eligible for this variance, Class A licensees must comply with all the provisions of MN Rules 4668.0855, Subp. 9 and 4668.0865. Violations of these rule parts will be assessed in the amounts authorized in MN. Rules 4668.0855, Subp. 10 and 4668.0865, Subp. 10.

III. DELEGATION OF INSULIN ADMINISTRATION
Waiver to MN Rule 4668.0100 Subp. 3

MN Rule 4668.0100, Subp. 3 is waived for persons qualified to perform home health aide tasks under part 4668.0100 who have been delegated the responsibility by a registered nurse to administer injectable insulin.

To be eligible for this waiver, Class A licensees must comply with MN Rules 4668.0855, Subparts 2, 3, 4, 5, 6, 7, and 9. Consistent with 4668.0855, Subp. 6, unlicensed persons may not draw up injectables, including insulin. Violations of this rule part will be assessed in the amounts authorized in MN Rules 4668.0855, subp. 10.

IV. ELECTRONICALLY TRANSMITTED ORDERS
Variance to MN Rule 4668.0150

By variance to MN Rule 4668.0150, Class A licensees may receive electronically transmitted orders for clients in Housing with Services Establishments. To be eligible for this variance, Class A licensees must comply with all the provisions of MN Rules 4668.0860, Sub. 7. Violations of this rule part will be assessed in the amounts authorized for MN Rules 4668.0860, sub.. 10.

This Informational Bulletin remains in effect until Class A licensure requirements are revised.

Permitting Class A licensee to centrally store medications for clients in Housing with Services Establishments consistent with Mn Rule 4668.0865 and violations at the level authorized for 4668.0865 and Mn Rule 4668.0855, Subp. 9 and violations at the level authorized for 4668.0855, Subp.9.

MN Rule 4668.0865 states:

Subp. 2 Nursing Assessment and Service Plan. For a client whom medications will be centrally stored, a registered nurse must conduct a nursing assessment of a client's functional status and need for central mediation storage and develop a service plan for the provision of that service according to the client's needs and preferences. The service plan must include the frequency of supervision of the task and of the person providing the service for the client according to part 46668.0845. The service plan for central storage of medication must be maintained as part of the service plan required under part 4668.0815.

Subp.3 Control of Medications. A registered nurse or pharmacist must establish and maintain a system that addresses the control of medications, handling of medications, medication containers, medication records and disposition of medications.

B. The system must contain at least the following provisions:

a statement of whether the staff will provide medication reminders, assistance with self- administration of medication, medication administration or a combination of those services;
a description of how the distribution and storage of medications will be handled, including a description of suitable storage facilities;
the procedures for recording medications that clients are taking;
the procedures for storage of legend and over-the-counter drugs;
a method for refrigeration of biological medications; and
the procedures for notifying a registered nurse when a problem with administration, record keeping, or storage of medications is discovered.

Subp.4. Over the counter drugs. An over-the-counter drug may be retained in general stock supply and must be kept in the original labeled container.

Subp. 5. Legend drugs. A legend drug must be kept in its original container bearing the original prescription label with legible information stating the prescription number, name of drug, strength and quantity of drug, expiration date of time-dated drug, directions for use, client's name, prescriber's name, date of issue and the name and address of the licensed pharmacy that issued the medications.

Subp.6. Medication samples. A sample of medication provided to the client by an authorized prescriber may be used by that client, and must be kept in its original container bearing the original label with legible directions for use. If assistance with self-administration of medication or medication administration is provided by the assisted living home care provider licensee, a client's plan of care must address the use of a medication sample.

Subp. 7. Prohibitions. No legend drug supply for one client may be used or saved for the use of another client.

Subp. 8. Storage of drugs. An assisted living home care provider licensee providing central storage of medications must store all drugs in locked compartments under proper temperature controls and permit only authorized nursing personnel to have access to the keys.

Subp. 9. Storage of Schedule II drugs. An assisted living home care provider licensee providing central storage of medications must provide separately locked compartments, permanently affixed to the physical plant or medication cart, for the storage of controlled drugs listed in Minnesota Statutes, section 152.02, subdivision 3.

MN Rule 4668.0855, Subp. 9 states:

Subp 9. Medication records. The name, date, time, quantity of dosage, and the method of administration of all prescribed legend and over-the-counter medications, and the signature and title of the authorized person who provided assistance with self-administration of medication or medication administration must be recorded in the client's record following the assistance with self-administration of medication or medication administration. If assistance with self-administration of medication or medication administration. If assistance was not completed as prescribed, documentation must include the reason why it was not completed and any follow up procedures that were provided.

III. DELEGATION OF INSULIN INJECTIONS
Waiver to MN Rule 4668.0100 Subpart 3

A person who has met the qualifications for persons who perform home health aide tasks under 4668.0100 and has been delegated the responsibility by a registered nurse, may administer injectable insulin. A person under 4668.0100 may not draw up injectables, including insulin.

IV. ELECTRONICALLY TRANSMITTED ORDERS
Variance to MN Rule 4668.0150

Medication and Treatment orders permitting Class A to electronically transmit treatment orders for clients in housing with services settings consistent with MN rule 4668.0860 Subp. 7; and violations at the level authorized for 4668.0860 Supb. 7.

Supd. 7. Electronically transmitted orders.

An order received by telephone, facsimile machine, or other electronic means must be kept confidential according to Minnesota Statutes, sections 144.335 and 144A.44.
An order received by telephone, facsimile machine, or other electronic means must be communicated to the supervising registered nurse within one hour of receipt.
An order received by electronic means, not including facsimile machine, must be immediately recorded or placed in the client's record by a nurse and must be countersigned by the prescriber within 62 days.
An order received by facsimile machine must have been signed by the prescriber, and must be immediately recorded or a durable copy must be placed in the client's record by a person authorized by the assisted living home care provider license.

MINNESOTA RULES CURRENT AS OF AUGUST 17, 1999

MEDICATION ADMINISTRATION AND ASSISTANCE WITH SELF-ADMINISTRATION OF MEDICATION. 4668.0855

Subpart 1. Scope. This part applies to an assisted living home care provider licensee that provides medication administration or assistance with self-administration of medication by unlicensed personnel.

Subp. 2. Nursing assessment and service plan. For each client who will be provided with assistance with self-administration of medication or medication administration, a registered nurse must conduct a nursing assessment of each client's functional status and need for assistance with self-administration of medication or medication administration, and develop a service plan for the provision of the services according to the client's needs and preferences. The service plan must include the frequency of supervision of the task and of the person providing the service for the client according to part 4668.0845, and must be maintained as part of the service plan required under part 4668.0815.

Subp. 3. Delegation by a registered nurse. A registered nurse may delegate medication administration or assistance with self-administration of medication only to a person who satisfies the requirements of part 4668.0835, subpart 2, and possesses the knowledge and skills consistent with the complexity of medication administration or assistance with self-administration of medication, only in accordance with Minnesota Statutes, sections 148.171 to 148.285.

Subp. 4. Training for assistance with self-administration of medication or medication administration.
Before the registered nurse delegates the task of assistance with self-administration of medication or the task of medication administration, a registered nurse must instruct the unlicensed person on the following:

(1) The complete procedure for checking a client's medication record;

(2) Preparation of the medication for administration;

(3) Administration of the medication to the client;

(4) Assistance with self-administration of medication;

(5) Documentation, after assistance with self-administration of medication or medication administration, of the date, time, dosage, and method of administration of all medications, or the reason for not assisting with self-administration of medication or medication administration as ordered, and the signature of the nurse or authorized person who assisted or administered and observed the same; and

(6) the type of information regarding assistance with self-administration of medication and medication administration reportable to a nurse.

Subp. 5. Administration of medications. A person who satisfies the requirements of subpart 4 and has been delegated the responsibility by a registered nurse, may administer medications, orally, by suppository, through eye drops, through ear drops, by use of an inhalant, topically, by injection, or through a gastrostomy tube, if:

A. The medications are regularly scheduled; and

B. In the case of pro re nata medications, the administration of the medication is reported to a registered nurse either:

(1) Within 24 hours after its administration; or

(2) Within a time period that is specified by a registered nurse prior to the administration.

Subp. 6. Limitations on administering medications. A person who administers medications under subpart 3 may not draw up injectables. Medication administered by injection under subpart 5 is limited to insulin.

Subp. 7. Performance of routine procedures. A person who satisfies the training requirements of subpart 4 may perform assistance with self-administration of medication or medication administration if:

A. Before performing the procedures, the person is instructed by a registered nurse in the proper methods to perform the procedures with respect to each client;

B. A registered nurse specifies in writing specific instructions for performing the procedures for each client;

C. Before performing the procedures, the person demonstrates to a registered nurse the person's ability to competently follow the procedures;

D. The procedures for each client are documented in the client's records; and

E. The assisted living home care provider licensee retains documentation by the registered nurse regarding the person's demonstrated competency.

Subp. 8. Documentation. An assisted living home care provider licensee must retain documentation in the personnel records of the unlicensed personnel who have satisfied the training requirements of this part.

Subp. 9. Medication records. The name, date, time, quantity of dosage, and the method of administration of all prescribed legend and over-the-counter medications, and the signature and title of the authorized person who provided assistance with self-administration of medication or medication administration must be recorded in the client's record following the assistance with self-administration of medication or medication administration. If assistance with self-administration of medication or medication administration was not completed as prescribed, documentation must include the reason why it was not completed and any follow up procedures that were provided.

Subp. 10. Schedule of fines. For a violation of the following subparts, the stated fine shall be assessed:

A. subpart 2, $350;

B. subpart 3, $350;

C. subpart 4, $300;

D. subpart 5, $350;

E. subpart 6, $500;

F. subpart 7, $350;

G. subpart 8, $50; and

H. subpart 9, $300.

STAT AUTH: MS s 144A.45
HIST: 24 SR 141

MEDICATION AND TREATMENT ORDERS. 4668.0860

Subpart 1. Scope. This part applies to an assisted living home care provider licensee when an authorized prescriber orders a medication or treatment to be administered by the licensee.

Subp. 2. Prescriber's order required. There must be a written prescriber's order for a drug for which an assisted living home care provider licensee provides assistance with self-administration of medication or medication administration, including an over-the-counter drug.

Subp. 3. Medication and treatment orders. A medication or treatment must be administered by a nurse qualified to implement the order or by an unlicensed person under the direction of a nurse and the supervision of a registered nurse, according to part 4668.0845.

Subp. 4. Authorizations. An order for medication or treatment must be dated and signed by the prescriber, except as provided by subparts 6 and 7, and must be current and consistent with the nursing assessment required under part 4668.0855, subpart 2.

Subp. 5. Content of medication orders. An order for medication must contain the name of the drug, dosage indication, and directions for use.

Subp. 6. Verbal orders. Upon receiving an order verbally from a prescriber, a nurse must:

A. Record and sign the order; and

B. Forward the written order to the prescriber for the prescriber's signature no later than seven days after receipt of the verbal order.

Subp. 7. Electronically transmitted orders.

A. An order received by telephone, facsimile machine, or other electronic means must be kept confidential according to Minnesota Statutes, sections 144.335 and 144A.44.

B. An order received by telephone, facsimile machine, or other electronic means must be communicated to the supervising registered nurse within one hour of receipt.

C. An order received by electronic means, not including facsimile machine, must be immediately recorded or placed in the client's record by a nurse and must be countersigned by the prescriber within 62 days.

D. An order received by facsimile machine must have been signed by the prescriber and must be immediately recorded or a durable copy placed in the client's record by a person authorized by the assisted living home care provider licensee.

Subp. 8. Implementation of order. When an order is received, the assisted living home care provider licensee or an employee of the licensee must take action to implement the order within 24 hours of receipt of the order.

Subp. 9. Renewal of orders. A medication or treatment order must be renewed at least every 12 months or more frequently as indicated by the nursing assessment required under part 4668.0855, subpart 2.

Subp. 10. Schedule of fines. For a violation of the following subparts, the stated fine shall be assessed:

A. subpart 2, $350;

B. subpart 3, $350;

C. subpart 4, $350;

D. subpart 5, $350;

E. subpart 6, $350;

F. subpart 7, item A, $250;

G. subpart 7, item B, $300;

H. subpart 7, item C, $300;

I. subpart 7, item D, $300;

J. subpart 8, $500 per day; and

K. subpart 9, $100.

STAT AUTH: MS s 144A.45
HIST: 24 SR 141

CENTRAL STORAGE OF MEDICATION. 4668.0865

Subpart 1. Scope. This part applies to an assisted living home care provider licensee that provides central storage of medications.

Subp. 2. Nursing assessment and service plan. For a client for whom medications will be centrally stored, a registered nurse must conduct a nursing assessment of a client's functional status and need for central medication storage, and develop a service plan for the provision of that service according to the client's needs and preferences. The service plan must include the frequency of supervision of the task and of the person providing the service for the client according to part 4668.0845. The service plan for central storage of medication must be maintained as part of the service plan required under part 4668.0815.

Subp. 3. Control of medications.

A. A registered nurse or pharmacist must establish and maintain a system that addresses the control of medications, handling of medications, medication containers, medication records, and disposition of medications.

B. The system must contain at least the following provisions:

(1) A statement of whether the staff will provide medication reminders, assistance with self-administration of medication, medication administration, or a combination of those services;

(2) A description of how the distribution and storage of medications will be handled, including a description of suitable storage facilities;

(3) The procedures for recording medications that clients are taking;

(4) The procedures for storage of legend and over-the-counter drugs;

(5) A method of refrigeration of biological medications; and

(6) The procedures for notifying a registered nurse when a problem with administration, recordkeeping, or storage of medications is discovered.

Subp. 4. Over-the-counter drugs. An over-the-counter drug may be retained in general stock supply and must be kept in the original labeled container.

Subp. 5. Legend drugs. A legend drug must be kept in its original container bearing the original prescription label with legible information stating the prescription number, name of drug, strength and quantity of drug, expiration date of a time-dated drug, directions for use, client's name, prescriber's name, date of issue, and the name and address of the licensed pharmacy that issued the medications.

Subp. 6. Medication samples. A sample of medication provided to a client by an authorized prescriber may be used by that client, and must be kept in its original container bearing the original label with legible directions for use. If assistance with self-administration of medication or medication administration is provided by the assisted living home care provider licensee, a client's plan of care must address the use of a medication sample.

Subp. 7. Prohibitions. No legend drug supply for one client may be used or saved for the use of another client.

Subp. 9. Storage of Schedule II drugs. An assisted living home care provider licensee providing central storage of medications must provide separately locked compartments, permanently affixed to the physical plant or medication cart, for storage of controlled drugs listed in Minnesota Statutes, section 152.02, subdivision 3.

Subp. 10. Schedule of fines. For a violation of the following subparts, the stated fine shall be assessed:

A. subpart 2, $350;

B. subpart 3, $300;

C. subpart 4, $300;

D. subpart 5, $300;

E. subpart 6, $300;

F. subpart 7, $300;

G. subpart 8, $300; and

H. subpart 9, $300.

STAT AUTH: MS s 144A.45
HIST: 24 SR 141